POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH by POWER MEDICAL INTERVENTIONS, INC.

The Power Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Device Description

Power Circular Stapler Digital Loading Units® are single use, disposable, surgical stapling devices designed for creating a circular anastomosis between two tubular structures and/or tissue layers.

AI/ML Overview

This document describes a Special 510(k) Pre-Market Notification for a device called "Power Circular Stapler Digital Loading Units®". This is a surgical stapling device, and the submission is for a modification to an existing, cleared device (SurgASSIST® Circular Stapler Digital Loading Units®, K003277).

Due to the nature of this submission being a Special 510(k) for a surgical stapler device modification, the provided text does not contain information related to software-driven acceptance criteria or the type of study typically conducted for AI/ML-driven medical devices. The description focuses on mechanical device modifications and their functional equivalence to the predicate device.

Therefore, I cannot populate the requested table and answer the specific questions about AI/ML device studies (sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) because this information is not present in the provided text. The device is a mechanical surgical stapler, not an AI/ML diagnostic or predictive tool.

Here's a breakdown of what can be extracted and why the other information is absent:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Inferred from the document)	Reported Device Performance (Inferred from the document)
Functionality: Deliver two staggered rows of titanium staples on each side of a circular transection.	Cut and staple identically to the predicate device (K003277).
Indications for Use: Applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.	Same Indications for Use as the predicate device (K003277).
Performance in Surgery: Create a circular anastomosis between two tubular structures and/or tissue layers.	Functionally equivalent to the predicate device.
Safety: Device modifications maintain safety equivalent to predicate.	No specific safety issues mentioned; implied equivalence through the 510(k) clearance process.

Explanation for Inferred Criteria and Performance:
The document states, "The Power Circular Stapler Digital Loading Units® cut and staple identically to the predicate device, Circular Stapler Digital Loading Units® (K003277)." It also confirms, "The Power Circular Stapler Digital Loading Units® have the same indications for use and the same functionality as the previously cleared predicate Circular Stapler Digital Loading Units® (K003277)." In a Special 510(k) for a device modification, the primary "acceptance criterion" is typically demonstrating substantial equivalence in performance and safety to the predicate device, especially when the core mechanism and indications remain unchanged.

Missing Information (and why it's missing for this type of device):

2. Sample sized used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of an AI/ML algorithm. Testing for a mechanical device modification would typically involve bench testing, animal studies, or cadaver studies, but the specifics are not detailed in this high-level summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a surgical stapler is its mechanical performance (e.g., staple formation, tissue approximation, leak testing) and clinical outcome (e.g., successful anastomosis), but these details are not provided in the summary.
8. The sample size for the training set: Not applicable. There is no AI model being trained.
9. How the ground truth for the training set was established: Not applicable. There is no AI model being trained.

Summary of the Study for Substantial Equivalence:

The study proving the device meets the acceptance criteria (i.e., substantial equivalence) is implicitly a comparison study against its predicate device (K003277). The modifications made (reduced rigid length, relocated gearing, redesigned anvil clamping mechanism) are presented as not altering the fundamental stapling mechanism or the indications for use.

The statement, "The Power Circular Stapler Digital Loading Units® cut and staple identically to the predicate device," serves as the primary evidence presented in this summary for meeting the performance criteria. The "Predicate Comparison Chart in Section J" (not provided in this excerpt) would have contained the detailed technical comparison data. Such a comparison would typically involve engineering analysis, bench testing, and potentially some form of in-vitro or ex-vivo testing to demonstrate equivalent staple formation, strength, and sealing characteristics. However, these specific study details are not expanded upon in the provided K061649 summary.

Summary

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K061649
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SECTION E - Special 510(k) Summary

1 2006

In Accordance with 21 CFR Section 807.92 Power Medical Interventions® is submitting the following safety and effectiveness summary.

Submitter Information:

Power Medical Interventions, Inc. 2021 Cabot Blvd. Langhorne, PA 19047 267-775-8151 Ph 267-775-8123 Fax

Applicant:

Barbara J. Whitman

June 8, 2006 Date of Notification:

1. Name of Device:

Trade Name:	Power Circular Stapler Digital Loading Unit®
Common Name:	Circular Staplers with Implantable Staples
Classification Name:	Staple, Implantable, GDW

1. Predicate Devices:
  SurgASSIST® Circular Stapler Digital Loading Units®, Power Medical Interventions, Inc., K003277.

4) Device Description

Power Circular Stapler Digital Loading Units® are single use, disposable, surgical stapling devices designed for creating a circular anastomosis between two tubular structures and/or tissue layers.

5) Device Modification

The Power Circular Stapler Digital Loading Units® cut and staple identically to the predicate device, Circular Stapler Digital Loading Units® (K003277). The rigid length of the Power Circular Stapler Digital Loading Units® have been reduced by relocating portions of the gearing into the proximal end of the device, while redesigning the anvil clamping mechanism. There are Power

Image /page/0/Picture/18 description: The image shows a sequence of numbers, specifically "000013". The numbers are printed in a bold, sans-serif font, and they appear to be part of a label or identification code. The numbers are uniformly sized and spaced, with a period at the end.

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K061649
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Power Medical Interventions, Inc. Power Circular Stapler Digital Loading Units® Special 510(k) Device Modification PreMarket Notification - June 8, 2006

Circular Staplers which incorporate a retractable dilator that is attached to the distal end of the DLU. The dilator provides a tapered leading edge, which eases DLU insertion.

1. Indications For Use
  The Power Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
1. Comparison to Predicate Devices
  The Power Circular Stapler Digital Loading Units® have the same indications for use and the same functionality as the previously cleared predicate Circular Stapler Digital Loading Units® (K003277). Both the Power Circular Stapler Digital Loading Units® and the Circular Stapler Digital Loading Units® deliver two staggered rows of titanium staples on each side of a circular transection. For further details, please see the Predicate Comparison Chart in Section J of this submission.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2006

Power Medical Interventions % Ms. Barbara J. Whitman Regulatory Affairs Manager 2021 Cabot Boulevard West Langhorne, Pennsylvania 19047

Re: K061649

Trade/Device Name: Power Circular Stapler Digital Loading Units® Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 7, 2006 Received: August 8, 2006

Dear Ms. Whitman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This

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Page 2 - Ms. Barbara J. Whitman

letter will allow you to begin marketing your device as described in your Section 510(k) nremarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Fuc Pdo Vr

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Power Medical Interventions, Inc. Power Circular Stapler Digital Loading Units® Special 510(k) Device Modification PreMarket Notification - K061649 Request for Additional Information - July 12, 2006

Indications for Use

510(k) Number (if known): K061649

Device Name: Power Circular Stapler Digital Loading Units®

Indications for Use:

The Power Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Note: The Indications For Use for the Power Circular Stapler Digital Loading Units® are identical to that of the predicate device, Circular Stapler Digital Loading Units®, which were cleared to market via K003277.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign Off

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(Division Sign-O Division of General, Restorative, and Neurological Devices

510(k) Number K061645

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.